Early Treatment for HCV: New York State of Mind

Clinical Guidelines for the Medical Management of Hepatitis C

New York State Department of Health

E. Treatment of Hepatitis C

The primary goal of HCV therapy is to achieve a SVR, defined as an undetectable HCV RNA 6 months after stopping antiviral therapy. Secondary goals of antiviral therapy include improvements in histology, quality of life and prevention of hepatocellular carcinoma. Antiviral therapy is approved by the Food and Drug Administration (FDA) for patients with persistently abnormal liver enzymes, detectable HCV RNA and an abnormal liver biopsy. Recent data have shown that patients with normal liver enzymes, detectable HCV RNA and an abnormal liver biopsy respond to therapy at similar rates as those with abnormal liver enzymes.⁵⁵

The efficacy of HCV treatment has improved over the past decade. Initial treatment consisting of interferon alpha has been replaced by pegylated interferon and now by combination therapy using pegylated interferon and ribavirin. Efficacy varies depending on multiple factors especially viral genotype, but achieving sustained viral suppression in 50% of patients can be expected.

1. Patient Evaluation and Treatment

Recommendations

Treatment should be considered for all patients with detectable HCV RNA and an abnormal liver biopsy, regardless of the presence or absence of liver enzyme elevation.

Prior to making a decision regarding treatment, patients should be evaluated with HCV RNA, HCV genotype, liver enzymes (ALT), and liver biopsy, unless contraindicated. The decision to initiate antiviral therapy should be made based upon the willingness of the patient to undergo therapy, ability to regularly attend appointments, and agreement to use contraception to prevent pregnancy. The decision to initiate antiviral therapy should be made on an individualized basis that considers severity of liver disease, co-morbid conditions, the potential for serious side effects and the likelihood of response.

Patients with HCV infection on methadone maintenance therapy should not be considered ineligible for treatment.

The treatment of the actively using injection drug user is not contraindicated and may be appropriate under some circumstances. Patients with a history of well-controlled psychiatric disorders may be excellent candidates for antiviral therapy and should be under the care of a qualified mental health professional.

Treatment of HIV/HCV co-infected patients should be offered with pegylated interferon and ribavirin, unless contraindicated. Patients co-infected with HIV/HCV should be managed by experts in both viruses. The basic tenets of HCV management should not change, but the provider must be prepared for possible hepatotoxicity and drug-drug interactions. Further recommendations for the HIV/HCV co-infected patient are provided at: CRITERIA FOR THE MEDICAL CARE OF ADULTS WITH HIV INFECTION

All patients with CHC infection are candidates for antiviral therapy. These patients are defined by detectable serum HCV RNA and an abnormal liver biopsy consistent with chronic liver disease. Treatment is recommended for patients with significant inflammation or fibrosis.²³

There are relatively few contraindications to antiviral therapy although the decision to initiate therapy should be made after ensuring that the patient understands the risks and benefits of pegylated interferon and ribavirin. Current absolute contraindications to combination therapy include a known hypersensitivity to pegylated interferon and/or ribavirin, autoimmune hepatitis, decompensated liver disease, pregnant women, men whose female partners are pregnant and patients with hemoglobinopathies.^56,57 Many patients with hepatitis C will also have underlying mental illness such as depression. Uncontrolled psychiatric illness and suicidal ideations or attempts are contraindications to antiviral therapy. Patients with remote histories of suicidal ideation or attempt warrant further evaluation to assess suitability for treatment. On the other hand, patients whose psychiatric disorders are under control and who are regularly followed by mental health providers are often excellent candidates for antiviral therapy.

IDU is the most common mode for acquisition of HCV infection. Patients with a history of injection drug use who are no longer using recreational injection drugs are treated in the guidelines as noted above. Methadone use has not been shown to adversely affect SVR rates or interfere with patient adherence to medication regimens. Patients enrolled in methadone maintenance programs should be considered for antiviral therapy.⁵⁸

The treatment of actively injecting drug users is controversial and raises concerns related to adherence to therapy and the potential for re-infection. Patients actively using injection drugs should be offered drug counseling and psychiatric support services. Like all patients, treatment of the actively injecting drug using person should be based upon the willingness of the patient to undergo therapy, ability to regularly attend appointments for close monitoring, and agreement to use of contraception to prevent pregnancy.

2. Environmental Assessment and Support

Environmental support is an important part of patient assessment because treatment may be given for up to one year, and the adverse effects of treatment may incapacitate patients. A patient's living situation and household income should be addressed prior to treating treatment. Homelessness may be a significant problem, and the need for a support network for such patients should be assessed and arranged before the treatment. In addition, most formulations of pegylated interferon now require refrigeration. Family meetings can be helpful to prepare family members for side effects of treatment. Neuro-psychiatric side effects such as irritability and hostility can strain relationships if unexpected. These issues can be assessed with the collaboration of social services. Family and friends may need to help with activities of daily living including transportation to medical appointments. Home health nurses and case managers may be helpful in providing support at home.

3. Initiating Treatment

Recommendations

Prior to treatment, patients should have a baseline complete blood count (CBC), chemistry evaluations, serum creatinine, thyroid function tests, pregnancy tests in women, HIV testing, contraceptive counseling for men and women, and screening for depression.

Prior to initiating treatment, patients should be informed of the possible side effects of therapy to allow them to anticipate and manage with these side effects.

The treatment of choice for patients with chronic hepatitis C infection is combination pegylated interferon and ribavirin. Patients infected with genotype 1 or 4 should be treated for 48 weeks with combination pegylated interferon and ribavirin. The ribavirin dose should be 1000 mg a day in patients <75 kg and 1200 mg a day in patients >75 kg.

Patients infected with genotype 2 or 3 should be treated for 24 weeks with combination pegylated interferon and ribavirin. The ribavirin dose should be 800 mg a day.

Several treatments are licensed in the U.S. for the treatment of CHC. These agents include interferon alpha-2a, interferon alpha-2b, interferon alpha con-1, and interferon alpha-2b in combination with ribavirin; pegylated interferon alpha-2b alone and in combination with ribavirin; and interferon alpha-2b and pegylated interferon alpha-2a alone and in combination with ribavirin. Data from multiple clinical trials clearly supports the use of pegylated interferon in combination with ribavirin.

Pegylated interferon has been a major advance in the treatment of CHC. The concept behind the pegylation of interferon is to produce a molecule which maintains longer lasting therapeutic concentrations by optimizing both absorption and distribution while decreasing the rate of clearance and deceasing proteolysis. This is accomplished by the addition of a polyethylene glycol molecule [PEG] to standard interferon by way of a covalent bond. This PEG molecule is non-toxic polymer that is readily excreted in the urine. The PEG molecule can be either linear or branched. Larger PEG molecules produce greater reductions in renal clearance and provide more subcutaneous absorption.

Two pegylated molecules are currently being used in the U.S. Pegylated interferon alfa-2b (Peg-Intron; Schering-Plough) is a linear 12 KD molecule, and pegylated interferon alfa-2a (Pegasys; Roche) is a 40KD branched chain molecule. These products are both manufactured using recombinant DNA technology in an Escherichia coli system. Both products have dose related maximum concentrations. Pegylated interferon alfa-2a is given as a fixed dose whereas pegylated interferon alfa-2b is dosed according to patient weight.

One study compared once weekly pegylated interferon alfa-2a with standard interferon alfa-2a three times a week for 48 weeks in previously untreated patients with hepatitis C.⁵⁹ The SVR rate in the pegylated interferon group was 39% compared to a 19% response rate in the standard interferon group. The SVR rate of genotype 1 patients receiving peginterferon alfa-2a was 28%. The frequency and severity of adverse events was similar in both groups. Pretreatment factors that were associated with a sustained virologic response in this study, in order of significance, include genotype other than type 1, ALT quotient greater than three, HCV RNA level less than two million copies (Cobas Amplicor HCV-PCR version 2; Roche), body surface area less than 2 meters, lack of bridging fibrosis or cirrhosis, and age less than 40 years. Side effects were less with the group treated with pegylated interferon alfa-2a than the group that received standard interferon therapy.

The highest SVR rates in previously untreated patients with chronic hepatitis C have been reported with combination pegylated interferon and ribavirin. In one study of 1530 patients, a 54% SVR was reported in patients treated with pegylated interferon alfa-2b plus ribavirin.⁶⁰ This was compared to a 47% SVR rate in patients treated with three times a week standard interferon plus ribavirin. The response rates to pegylated interferon alfa-2b plus ribavirin for genotypes 1 and non-1 were 42% and 82%, respectively.² In a retrospective analysis of the data, the authors report that patients receiving more than 10.6 mg/kg of ribavirin had higher sustained response rates, regardless of treatment group. Another study showed that patients with genotypes other than type 1, regardless of ribavirin dose and treatment duration, had a sustained reponse of 80%, leading to the recommendation that non-type 1 patients can use a ribavirin dose of only 800 mg and can discontinue treatment after 24 weeks.⁶¹

Side effects between the groups receiving pegylated interferon alfa-2b and standard interferon were similar although there was significantly more fever, weight loss, nausea and injection site reactions in the group receiving pegylated interferon alfa-2b. Several studies have documented a decreased sustained viral response rates in African-American patients infected with hepatitis C when compared to Caucasians and Asian-Americans. One prospective study evaluating the SVR rates of African-Americans and whites receiving pegylated interferon alfa-2a plus ribavirin for 48 weeks, reported a response of 26% for blacks compared to 39% for whites.⁶²

4. Monitoring While on Treatment

Recommendations

Patients who do not achieve virologic suppression or a 2-log decrease in HCV RNA at 12 weeks may have therapy discontinued, although factors such as degree of fibrosis and tolerability of therapy should be considered.

Patients should have a CBC and chemistry evaluations 2 weeks after initiation of treatment to assess for potential toxicities. CBC, chemistry evaluations, and pregnancy tests in women should be done routinely at each follow-up visit and not less often then every 4-6 weeks during treatment.

Patients who achieve an end-of-treatment virological response should have HCV RNA testing performed 24 weeks after stopping treatment to evaluate for a SVR.

Erythropoetin alfa and granulocyte colony stimulating factor (G-CSF) may be used to treat anemia and neutropenia, respectively, in order to maintain the patient on full medication doses.

Providers should reference the full discussion of side effects of hepatitis C treatment in Appendix A.

One analysis of pegylated interferon alfa-2b plus ribavirin showed that genotype 1 patients who did not achieve either viral eradication or a drop in baseline HCV RNA by more than 2 log at 12 weeks of therapy had <1% chance of achieving a SVR. Patients who do not achieve this "early viral response" can have therapy discontinued. This action is both cost effective and can improve patient quality of life.⁶³ The key factor in achieving a sustained viral response with pegylated interferon and ribavirin appears to be the patient's ability to adhere to the treatment regimen. Adherence is directly related to side effects and tolerability. Better understanding of the toxicities and side effects of combination therapies and their management should lead to better outcomes. Common side effects of pegylated interferon plus ribavirin therapy include the development of flu-like symptoms, fatigue, alopecia, rash, cough, insomnia, anorexia, thyroid disease, injection-site reactions, vision disorders, anemia, neutropenia, and thrombocytopenia. Rarely, colitis, pancreatitis, and severe pulmonary disease have been observed on alfa-interferon and ribavirin therapy.^56,57

Ribavirin may cause birth defects and/or death to the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking pegylated interferon plus ribavirin. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of child-bearing potential and men must use two forms of effective contraception during treatment and for at least six months after treatment has concluded. Monthly pregnancy tests must be performed routinely throughout the treatment and follow-up phases.⁶⁴

Pegylated interferon and ribavirin have been found to be safe and effective in HCV mono-infection and in co-infection with HIV.^2,61 Safety and efficacy has not been established in patients who have received liver or other organ transplants, in patients who have failed other alpha interferon treatments and in patients under the age of 18.^56,57

Neutropenia is commonly seen with pegylated interferon alfa-2b, and 18% of those receiving pegylated interferon at 1.5 ug/kg required a dose reduction due to significant neutropenia. Anemia secondary to ribavirin was also common. Ribavirin dose reduction was seen in 9% of patients treated with pegylated interferon 1.5 ug/kg in combination with 800 mg of ribavirin, and in 13% of those treated with standard interferon and 1000-1200 mg of ribavirin.

5. Re-treatment of Patients Previously Treated for Hepatitis C

Recommendations

Re-treatment of inadequately treated patients is recommended with a combination of pegylated interferon and ribavirin.

Re-treatment of non-responders or relapsers to antiviral therapies other than a combination of pegylated interferon and ribavirin should be strongly considered.

Re-treatment of Patients Who Failed to Respond to Previous Therapies

A large segment of patients with hepatitis C fall into the category of those who did not respond previous to therapy. A careful history must be obtained in these patients to determine if re-treatment should be considered. Patients who did not respond to therapy fall into three general categories: (1) those who were inadequately or inappropriately treated initially, (2) non-responders and (3) relapsers. In addition, patients may fit into any of these three categories after treatments with interferon monotherapy, three-times-weekly interferon plus ribavirin, or pegylated interferon plus ribavirin.

Re-treatment of Inadequately or Inappropriately Treated Patients

Inadequately treated patients are those who either received less than the recommended doses of interferon or ribavirin or were treated for a shorter duration of therapy to make an appropriate assessment as to their response. It is important that all treated patients are encouraged to remain on the baseline dosages of interferon or ribavirin unless untoward effects necessitate dose reduction for a minimum of 12 weeks in order for an assessment of early viral response to be obtained. Inadequately treated patients should be considered for re-treatment with pegylated interferon and ribavirin if no contraindications are noted.

Re-treatment of Non-responders

In patients previously treated with interferon monotherapy, approximately 25-40% may achieve a SVR when treated with pegylated interferon and ribavirin.^66,67 Approximately 10% of patients who did not respond to three-times-weekly interferon plus ribavirin will have a SVR with pegylated interferon and ribavirin. Factors associated with a response to retreatment include non-genotype 1 infection, lower baseline HCV RNA levels, less fibrosis on liver biopsy and non-African-American race.^66,67 There currently are no published data on the re-treatment of patients who fail to respond to treatment with pegylated interferon and ribavirin.

Re-treatment of Relapsers

Relapse is defined as the reappearance of serum HCV RNA in a patient with previously undetectable HCV RNA at the end of antiviral therapy. Relapse following interferon monotherapy is more common than relapse following combination interferon and ribavirin therapy or combination pegylated interferon and ribavirin therapy.

Large studies show that often relapsers following monotherapy with interferon alone respond favorably to standard interferon plus ribavirin. It seems reasonable to presume that such relapsers will respond to combination pegylated interferon plus ribavirin. The growing problem facing physicians today is how to approach the patient who relapses following combination interferon plus ribavirin or combination pegylated interferon plus ribavirin therapy. Unfortunately, there are limited data currently available to address this issue.

6. Treatment of HCV-Infected Children

Recommendations

Diagnostic evaluation for the presence and severity of HCV infection, including liver biopsy, should be performed in children as in adults.

Therapy with standard interferon and ribavirin may be offered to children aged 3-17 years if given under the care of experienced physicians.

Antiviral therapy should not be administered to children under the age of three.

Children infected with HCV are less likely to manifest symptoms and are more likely to have normal or minimally abnormal liver tests compared with adults. They generally have a slower rate of progression to advanced liver disease. However, there are multiple factors that support treatment of HCV infection in children. These factors include the anticipated long duration of infection after early acquisition, relatively good tolerance of antiviral medications, and avoidance of social stigmatization. Nevertheless, careful selection of appropriate candidates for therapy is important. If a contraindication to current therapeutic agents is present, treatment should be withheld until this has resolved or until new agents are available. Children without contraindications to the medications used for hepatitis C should undergo liver biopsy to determine the presence and degree of fibrosis. In the absence of fibrosis, treatment may be deferred. If any degree of hepatic fibrosis is present, antiviral therapy for HCV should be considered. At present, in the U.S., the only therapy approved for children by the FDA is a combination of interferon alfa-2b and ribavirin. The results of several studies using interferon monotherapy or combination therapy with standard interferon and ribavirin indicate that SVR rates are as good or better than those achieved in adults. Children generally tolerate interferon therapy better than adults; in small numbers of children reported so far dose-dependent hemolytic anemia has been less severe than in adults.⁶⁸ Although safety data have not yet been developed, pegylated interferon in combination with ribavirin offers improved efficacy and should be considered in adolescents older than 16 years of age who are post-pubertal, or in younger children in the context of clinical trials. Multicenter trials are currently underway to determine the safety and effectiveness of other forms of therapy for HCV infection in children.⁶⁸ The safety and pharmacokinetics of hepatitis C therapies have not been determined for children younger than 3 years of age.

7. Treatment of Individuals with Acute Hepatitis C Infection

Recommendations

Although there are no controlled trials recommending treatment of acute HCV infection, the use of pegylated interferon monotherapy may prevent the development of CHC infection, although the duration of therapy in still unknown.

There are insufficient data to recommend the use of ribavirin in the acute setting.

Therapy should be deferred until 12 weeks after exposure, to allow for spontaneous clearance to occur, thus avoiding therapy.

The acute phase of HCV infection is seen as a window of opportunity during which the establishment of chronic hepatitis C and its associated morbidity may be prevented.²² A meta-analysis of trials of various interferon alfa monotherapy regimens showed an average SVR rate of 42%, although the quality of these trials was variable.⁶⁹

Acute HCV infection is seldom seen in clinical practice. Therefore, there is a paucity of well-designed, randomized controlled trials for the treatment of this patient.⁷⁰ One study reported that intensive treatment of acute hepatitis C with interferon alfa-2b resulted in a 98% SVR. Although there is no standard therapy for the treatment of acute hepatitis C, this study strongly suggests that treatment with interferon monotherapy at higher than standard doses is highly effective in eradicating acute infection.⁷¹ Two more recent studies have reported on the effectiveness of pegylated interferon monotherapy for acute hepatitis C.^72,73 These studies support initiating therapy after an initial waiting period of approximately 12 weeks after exposure to allow for spontaneous clearance to occur, thus avoiding therapy altogether.

New York DOC: Hilton, Hep C and Class Action.

I have more research to do on this case - and a ton more stories like it to post, though I don't want to be too discouraging. These are really pretty heart-breaking. I think it's important to show, though, that the corrections industry has a long history and pattern of neglect, and that nothing has changed in the prisons as far as Hep C goes in over 10 years - except that more of the population is infected and dying now. Julie and I walked into the middle of an on-going battle raging in different parts of the country; we just opened up another front in Arizona.

This came out in 2005. I'm writing to this guy for help telling our story, too. It's time to turn this thing around.

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Rotting Away

Thousands of New York inmates have hepatitis C. Only a few hundred get treatment.

Kai Wright

Village Voice
November 29, 2005

It's hard to imagine how a doctor could miss Jimi Hammerstein's primary health risk. The graying Brooklyn native spent most of the last 10 years upstate for slinging dope in Park Slope—back when the neighborhood was still in transition. "I remember when this neighborhood wasn't nothing like this," he says, laughing as he sits in a drop-in center for ex-offenders on Fourth Avenue, the Slope's still-gritty border with Downtown Brooklyn. "This was like, dope land!"

Dope land's geography extended into the prison compounds Hammerstein bounced between. His habit continued once he was inside, and just as intensely. Most inmates snort heroin rather than inject it, but as Hammerstein describes the scene, "You got the die-hard dope fiends like I was, where there's only one way to fly. If you're going to do any kind of substance, you might as well shoot it."

Hammerstein's commitment to the needle made him a textbook candidate for two of the modern era's most aggressive communicable diseases: HIV and hepatitis C—a deadly virus that, when left untreated, slowly devours your liver. He tested positive for HIV back in 1989, before he entered prison. He says he copped to the infection at the beginning of his two bids, but he'd never heard of hep C and claims no one— certainly not corrections health officials—ever asked him about it.

Only after his release last year did the questions begin. "People used to say to me, 'Oh, you're HIV; are you hep C too?' " Hammerstein remembers. "I'd say no. And they'd say, 'Oh, that's unusual.' " He'd shrug the idea off. "I'd been taking tests up north for years, and no one mentioned anything about hep C." His doc on the outside finally insisted he get tested, and in what should have been no surprise, he was positive.

Like Hammerstein, thousands of prisoners around the country are slowly dying from a wholly treatable disease because corrections officials are doing everything possible to avoid caring for them. New York is among the worst offenders, as by most estimates it boasts more inmates living with hep C than any other state. But after years of advocates and inmates fruitlessly lobbying for change, a series of recent lawsuits, including a class action case now pending in federal court, appears to have finally forced the state's hand.

Over the last three decades, hep C has been a stealthy but virulent sidekick to its celebrity sister HIV. Nearly 3 million people nationwide now have chronic infections—triple the HIV caseload. They are uniquely concentrated in prisons: At least 14 percent of New York's inmates are known to have hep C. And as these legions barrel toward the disease's end stage, in which the inflamed liver turns cirrhotic, they promise to collapse the teetering liver-transplant market. Already, hep C is the number one reason for swapping out a liver; the waiting list for transplants is 17,000 people deep and growing. The sooner you start treatment, the less likely you'll need one.

In response to growing awareness about the epidemic—and its concentration among drug users who cycle in and out of incarceration—the state corrections department says it now offers tests to all incoming prisoners whose profiles raise red flags, as Hammerstein's should have. But even for those who get screened, learning you've got the disease is where, for most, the process ends. According to a Justice Department census, as of 2000, only about 300 of the state's estimated 10,000 hep C–positive inmates were being treated.

Prison health advocates charge this dismal rate is no accident. Coincidentally or not, treating hep C is one of the more expensive tasks in medicine. The multi-drug regimen can cost as much as $35,000 per patient. Corrections already spends almost $23 million a year on AIDS meds, nearly 40 percent of its whole pharmacy budget.

Until mid October, when the department began revising its policies in response to ongoing litigation, any inmate needing hep C treatment who had a history of using drugs—as does almost everyone with the virus—was required to first enroll in a six-month class for users. The official approach, which has been slowly shifting over the last couple of years, originally forced inmates to complete the course before getting treatment. It was expansive and unbending: If you'd ever done drugs or alcohol in your life, you had to take the class.

"You got guys that been in the system eight, nine, 10 years," scoffs Rahiem (not his real name), a hep C–positive lifer at the medium-security facility in Auburn who refused to take the drug class and so hasn't gotten treatment. "They don't have no record of drug use from disciplinary actions. But they're denied treatment." Rahiem wears long gray dreadlocks and stares with measured intensity when insisting that he last got high in 1973. But his old girlfriend once got charged with smuggling whiskey into the visiting room, he says, so now he's stuck with a user label.

"These rules are barriers that they set up," complains Romeo Sanchez, a hep C–positive ex-offender who organizes prison activism at the New York City AIDS Housing Network, "because they don't want to pay for it."

But as Robert Hilton found out, even if you go along with the rules, the outcome is often the same: no treatment. Hilton is the lead plaintiff in the new class action, filed in federal court on August 17.

Hilton began treatment for hep C at Bellevue in 2002. But a few months after starting, he became homeless, and his treatment was interrupted. In August 2004, he was locked up on a parole violation and shipped upstate to Altona. Upon intake there, he underwent a routine exam at which he told doctors about his infection, the resulting liver disease, and his treatment history.

But the medical staff waited two months to conduct its own tests, according to the complaint, and a full seven months to recommend him for treatment. Then Chief Medical Officer Lester Wright ruled Hilton couldn't start until he took drug addiction classes, even though no previous doctor in or out of the system had suggested it and even though Hilton professed to have not used drugs in 13 years—much of which time he spent passing drug tests as a parolee.

Hilton acquiesced and signed up for the class—only to be put on a lengthy waiting list. He was then transferred to another facility, where counseling staff again tried to enroll him in an addiction class. This time, his enrollment was turned down because he would be eligible for parole before the class finished. "As antiretroviral treatment continues to be denied on the basis of this catch-22," the class action complaint notes, "Mr. Hilton's liver continues to deteriorate."

The state declined to comment on this and other suits it now faces.

In previous suits, the corrections department has offered a reasonable-sounding defense. Hep C treatment is no joke—at least a shot a week and daily pills that can cause depression and flu-like symptoms similar to those of heroin withdrawal. Even the regular needle use can be traumatic for someone kicking an old habit. So the department worries about triggering relapses. And all credible medical guidelines stress that no one who's actively using drugs or alcohol should start treatment without getting sober, lest they fail to complete the regimen.

The stakes are high: If you start and don't finish, your virus will likely mutate, developing the sort of drug resistance we've heard so much about with HIV.

Critics, however, point out that all of the guidelines cited by corrections warn only against treating active users. The concern over relapse is the department's own.

In early November, the prison officials submitted a sweeping policy change to the U.S. District Court for the Northern District of New York, asking that a central part of Hilton's case be dismissed based on that change. The new policy removes the drug abuse class requirement but maintains an insistence that inmates have "no evidence of active substance abuse" in the previous six months. Those with evidence of such will be evaluated on a case-by-case basis.

Alexander Rienert, an attorney with Koob & Magoolaghan, which is leading the Hilton class action and has led a number of previous hep C suits, says that's not near good enough. He wants to see a far more detailed portrait of how the system will scale up treatment—and how it will get those it has previously turned away into treatment. "What Dr. Wright is saying is, trust us, you don't have to be involved anymore," scoffs Rienert. "But our experience is, the only time an individual gets treated is when an attorney has stepped in."

Moreover, Rienert says he's already received at least one new complaint from an inmate who has been denied treatment based on his failure to take a drug abuse class.

Milton Zelermyer, a staff attorney with Legal Aid's Prisoners' Rights Project, adds that there remain plenty of ways for corrections to ration treatment. Already, the prisons only test certain inmates for hep C, and as Hammerstein's experience shows, many likely candidates slip through unscreened. But effective hep C screening and treatment also require extensive diagnostics, including regular blood tests and a liver biopsy—just the sort of thing the department delayed for months before denying Hilton based on the drug class rule. So the new policy looks like progress, Zelermyer says, but "how it works in reality is another question."

Prison health advocates say the system's failure to deal adequately with hep C is just the latest disaster to come from letting prison guards control public health. Even as the narrow legal battle over hep C intensifies, advocates are pressing a broader legislative reform. Of course, for activists in Albany, reforms for guys like Rahiem and Hammerstein and Hilton have been the most dead on arrival.

The corrections department's health care challenge is already massive—it runs what amounts to the nation's largest HIV medical practice, for instance. Yet it is exempt from Department of Health oversight because state law considers its facilities more akin to private colleges than public hospitals. The state assembly wants that law changed, but neither the health department nor corrections wants to be part of an arranged marriage; bills calling for it have twice stalled in the senate.

And that leaves dying inmates' futures in the hands of the courts. "There could be something out there for you—whatever medicine, whatever program, whatever doctor you have to see—and they ain't telling," Hammerstein complains, "because the facility don't want to go for the money."

Our most insidious virus, and our prisoners.

Here's a historical perspective on Hep C emerging as a crisis in U.S. prisons. This came out about 9 years ago, but is still quite relevant - not much progress has been made since then - not in terms of access to treatment for prisoners, anyway. Some progress has actually been made in treatment since this article came out, but the more effective/less toxic drugs are more expensive, too.

The main difference now as far as prisons go seems to be that the incidence and seriousness of Hep C is downplayed because they realize how expensive it would be to treat people. Our "epidemic" of the turn of the millenium has thus settled in, and taken hold among the poor and institutionalized. Coping with HCV infection and associated liver disease has become more of a way of life among the US jail and prison population than dealing with HIV/AIDS is.

Still, just because we've grown used to it, doesn't mean we should let it go on any longer. - Peg

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Hepatitis C : A Silent Epidemic Strikes U.S. Prisons

by Silja J. A. Talvi
May 07, 2001

It's been called the nation's most insidious virus.

In a medium-security prison in La Grange, Kentucky, Anthony Nicholas Ware has got it. And at F.C.I. Coleman, a federal prison in Florida, Raymond James Hannum has got it as well.

A 'silent epidemic' that has swept the nation, hepatitis C virus (or HCV) is now the most common, chronic, blood-borne infection in the U.S. And it's precisely the stealthy, long-term silence of the virus that makes it as dangerous as it is. Because hepatitis C often causes no noticeable symptoms for up to 20 or 30 years after infection, most of those who are infected have no idea they are living with the potentially life-threatening infection.

The Damage Done

Conservatively, it's estimated that some 4 million Americans are now infected with the hepatitis C virus (HCV). By comparison, less than 1 million Americans are infected with HIV, the virus that causes AIDS.

And the nation's 2 million prisoners aren't even included in that estimate. While the number of new HCV infections in the nation has declined over the last decade, the incremental progress that has been made on educating and testing the general public is now severely threatened by what amounts to staggering infection rates behind bars.

By many accounts, the nation's prison populations are harboring the highest concentrations of HCV in the country. From state to state, between 20% to 60% of the current national inmate population is believed to harbor the virus, which can lead to chronic liver disease, cirrhosis and liver cancer.

There is no vaccine--or foolproof cure--for HCV.

Don't Ask, Don't Tell

In response, state prison administrators have been implementing varied and divergent approaches to address the rates of infection.

Some state prison systems, including Oklahoma's, have gone so far as to adopt a "don't ask, don't tell" policy as a way of avoiding costs affiliated with treatment of HCV. Faced with 28% and 37% infection rates among male and female inmates, respectively, the Texas state prison system took a different approach and drafted a plan last year to provide HCV testing, monitoring and treatment to those with chronic infections.

Other state correctional systems, including those in New York and California, say they provide testing upon request, and treatment if a prisoner can pass certain criteria.

But prisoners and their advocates insist that too little is being done, too late. The bottom line, they say, comes down to money, and not the welfare of inmates--or the community at large.

"Prisoners are going in expecting to do 10 to 15 years, and they're ending up with a death sentence," says Jackie Walker, AIDS Information Coordinator for the National Prison Project of the American Civil Liberties Union (ACLU), in Washington, D.C. "They're not getting the [medical] treatment that they deserve to receive."

Often, says Walker, prison officials cite the high cost of treatment to prisoners as the reason for the denial of treatment.

And treatment is expensive. Only two antiviral drugs are currently approved for use in treating HCV: interferon and ribavirin. Standard treatment per person, per year, can run from $8,000-$20,000. HCV medications are usually given over the course of one year.

Nor is drug therapy guaranteed to work. According to the Centers for Disease Control and Prevention (CDC), interferon has a 10 to 20 percent success rate when used alone. Combination therapy, using both interferon and ribavirin, is effective 30 to 40 percent of the time. Both drugs are known to have potentially severe side effects.

"This is an area where, ultimately, the patient should be able to choose whether to go on the treatment. But in [the prison system], that's not the way it works," says Jack Beck, a Supervising Attorney of the Prisoner's Rights Project of the Legal Aid Society in New York. "If someone knows what the risks and benefits are, they should be able to receive treatment as long as it's within medical guidelines. And that is not currently the case."

Beck, who has been involved in a case against the New York Department of Corrections for over a decade relating to the care of HIV-positive prisoners, says that he and others believe upwards of 30 to 40 percent of all inmates are infected, amounting to roughly 25,000 prisoners. Co-infection of HIV and HCV, according to

Beck, is also very high among the prisoners.

But only slightly over 100 inmates are currently receiving treatment, says Beck, out of more than 70,000 prisoners statewide.

That number is as low as it is, he says, because the diagnostic process in prison can drag on for months, and the criteria for treatment is very difficult to meet. "I believe part of the strategy [of prison officials] is to "filter" as much as possible, and to restrict the number of people on therapy, because if they really started treating all the people who are infected, the cost would be phenomenal."

The New York State Department of Corrections did not provide a response to this allegation or to general questions about treatment policies.

Cruel & Unusual Punishment

Beck and other advocates for prisoners say that not treating inmates in need of care is both a violation of the 8th amendment (prohibiting "cruel and unusual punishment"), as well as a violation of a landmark 1976 Supreme Court ruling in Estelle v. Gamble, which determined that inmates have a right to adequate medical care for serious medical needs.

People at particular risk for infection include past or present injection drug users (IDUs), medical care workers exposed to contaminated blood, and those who received blood transfusions before 1992, when a screening test was widely implemented. According to the CDC, roughly 20 percent of recent cases of HCV infection are due to sexual activity. Unsterilized tattoo or piercing equipment, as well as intranasal drug use also puts people at higher risk for HCV.

Some 10,000 deaths a year are currently attributed to chronic HCV infection, and the CDC has predicted that this number will triple in the next 20 years. HCV infection is also the most common reason for liver transplantation in the U.S. One transplant can easily cost over a quarter-million dollars.

Dying For Treatment

Anthony Nicholas Ware, a 42-year-old inmate serving a 22-year-sentence at the medium-security Luther Luckett Correctional Complex in La Grange, Kentucky, hopes that he will receive treatment before his HCV infection worsens significantly. Already, says Ware, he gets severely fatigued, and suspects that his infection has progressed to the middle, or moderate fibrosis stage.

Ware, who has joined a lawsuit against the correctional facility, can only guess at the status of his HCV infection because the prison has yet to perform a requested liver biopsy. Ware says that he has been requesting additional testing and treatment for his HCV since, and his requests to treat himself with herbs and vitamins were thwarted. Despite his doctor's approval, says Ware, he could not obtain the prison's permission to order liver-cleansing products like milk thistle from outside vendors.

Alan S. Rubin, a Louisville-based attorney representing Ware and roughly 50 other inmates in their complaint against the Luther Luckett Correctional Complex, says the prison has always maintained that treatment is available, but that no one was able to meet strict treatment criteria. The list of exclusionary criteria, obtained by this reporter, mandates that inmates who are HIV-positive, and those who have a history of illicit drug use in the preceding 12 months, cannot be treated.

Already, says Rubin, at least two people have died behind bars at this prison because of complications from HCV. And he continues to receive letters on a weekly basis from inmates who are learning that they're HCV-infected and want to be monitored and treated.

"It's not right," says Rubin, who points to testimony from Kentucky's Department of Corrections that one-third of inmates are likely infected with HCV. "In the next five to ten years, if something doesn't change, we're going to see the death rates from liver disease skyrocketing among prisoners and among those who have been recently paroled."

Rubin has won a single, significant legal victory on the issue of HCV treatment in the case of Michael Paulley, an Army veteran serving a 20-year sentence at Luther Luckett. Paulley tested positive for HCV and had already developed cirrhosis of the liver when he was seen by a hepatitis specialist, Dr. Bennett Cecil, at the Louisville Veterans Affairs Medical Center.

Although the Veteran's Affairs office was willing to pay for Paulley's treatment, the Corrections Department denied him that opportunity, saying that he did not meet the prison's medical guidelines for drug therapy. Rubin, in turn, argued that the Corrections Department was using those guidelines as a pretext for denying all prisoners treatment for HCV for fear of the costs involved.

In March, Federal Judge John Heyburn II agreed, and issued an injunction ordering the prison to allow Paulley to be treated.

"Money, not medicine, was the driving force behind the department's decision," wrote Magistrate Judge C. Cleveland Gambill in his findings to Judge Heyburn.

Warden Larry Chandler's office did not respond to a request for an interview.

Where Did I Get That?

"Prisoners have a moral and legal right to medical care," says Dr. Bennett, who specializes in treating hepatitis in Louisville, and who advocates that all prisoners, as a first step, should be tested for HCV infection and told of their status.

In the Luther Luckett Correctional Facility--as in most other state prisons in the country--no formal prevention or peer education program specifically geared toward HCV currently exists.

Interviewed by phone from prison, Anthony Ware explains that he only discovered his HCV status after going through the state's Open Records Act and paying for copies of all of his lab work.

"There it was: hepatitis C," says Ware. "I thought, 'Oh my God, where did I get that?"

That situation, says Judy Greenspan of the prisoner's advocate group, California Prison Focus (CPF), is being seen in some of California's prisons as well.

"Mostly, we've found that when prisoners have tested [positive for HCV], they haven't been told," says Greenspan. "People find out, for instance, when they're told they're not eligible for a job in the kitchen because they have hepatitis. That's the first they hear that they even took the test. Obviously, they're doing some sort of routine screening, somewhere. But most people are not being informed of their status."

Terry Thornton, Communications Director for the California Department of Corrections, explains that inmates are medically evaluated upon entry to the CDC, and may request medical attention when they have health questions or concerns. "Hepatitis testing is done when medically appropriate as indicated by history, physical examination, laboratory testing showing abnormalities, or by inmate request," she explains.

The California state prison system is, in fact, one of the few that has taken the initiative of completing a comprehensive study of how prevalent HCV is in the prison population. A March 1996 research study, completed in cooperation with the California Department of Health Services, demonstrated that the rates of infection among incoming inmates were 54.5 percent for women, and 39.4 percent for men. Among HIV-positive men, 61.3 percent were found to be co-infected with HCV, while HIV-positive women were found to have an astounding 85 percent co-infection rate with HCV.

But treatment for HCV is available in California state prisons, answers Thornton, and includes treatment for those who are co-infected with HIV. "Inmates are treated on a case-by-case basis," she says. "We treat patients for hepatitis C if they have otherwise healthy medical parameters and continue to do well while on the hepatitis medications. Many have successfully completed such therapy."

Peer education programs are continuing to expand, she adds. "The key here is to educate, working toward elimination of the source for disease transmission."

But budgetary restrictions are likely to prevent the implementation of more widespread treatment. In fiscal year 99/00, the Department of Corrections was funded only $325,000 to provide drug treatment. By the Department's own estimates, it costs $12,000-$20,000 per year, per patient, to treat HCV. Even on the low end of that scale, only 27 inmates would be eligible for a full course of drug treatment, out of a current state prison population of over 161,000 men and women.

Greenspan worries that more prisoners will die behind bars in the interim. "The tragedy about the hepatitis C epidemic is that we're finding out about it in the sundown years of the AIDS activist movement," says Greenspan. "The mass activism [around HIV] has faded, and trying to get people motivated about this issue is difficult because most people infected [with HCV] have a history of injection drug use, are mostly poor people of color, and people who are in prison." *****

"For many people who are in an out of the prison system, the only time they access medical care is on the inside. That's their reality," adds Greenspan. "If the system doesn't want to provide medical care, then they shouldn't lock up so many people."

Walker, of the ACLU's National Prison Project, insists that Americans have to begin thinking of prisons "as part of the community," on both humanitarian and public health grounds.

"The majority of people are not in there for extreme, violent crimes," she says. "The majority are in there for non-violent crimes, doing time for five, ten or 15 years. These are people who are going to be returning to our communities. Do we want people coming back out sicker than they were when they went in?" [ L i P ]

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Author: Silja J.A. Talvi is a Seattle-based journalist who frequently reports on prison and criminal justice issues. Different versions of this story have appeared in High Times and Prison Legal News.

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